Regulatory Affairs Manager (full time) - global Medical Devices
Posted on Jan 29, 2020 by NES IT
NES Global Talent in Switzerland focuses purely in the Life Science sector where we support the Pharma, Medical Device, Biotech industries and work on QA, Technical and Regulatory positions. With a database that consists of over 2000 Life Science involved talents based in Switzerland and a contact that covers 90% of the job seekers we advertise our clients through all recruitment rotes on a daily basis.
Currently we support one of our clients in the Medical Device industry in Zug. In order to strengthen their team there, we are looking for an experienced professional to join them as the Regulatory Affairs manager for their global products. Their current and upcoming global projects in Q1 and Q2 predict growth in the RA department and they've reached to us for our support.
- Technical documentation handling according to specific international laws and guided documents (medical devices)
- Establishment and maintenance of technical documentation and international registration documentation (STED/CSDT)
- Responsibility with the establishment of conformity assessment (ER-Checklist) and draft issuance of the Declaration of Conformity
- Establishment and maintenance of the Regulatory Process related documentation within the product life cycle and review and release of marketing materials and labelling
- Support the establishment, maintenance and optimization of Regulatory Affairs owned or relevant processes and process related documents
- Actively consult and support teams thorough the product life cycle with products safety licensing, standards and guided documents, risk management
- Support of product development projects and change control activities such as testing (standards IEC 60601-1, environmental and packaging testing, sterilization, EMC, biocompatibility)
- Compilation and implementation of the relevant registration documentation with cooperation with a responsible person or specific authorities (worldwide)
- BSc or MSc in Life Science studies, or a corresponding industry experience
- Experience in CFR 820, MDD, MDR, ISO 13485 (international country specific laws are a plus)
- 2-3 years of experience in RA (International products/markets) in Medical Device/Technology field
- Fluency in English, German and other languages are a plus
- Detailed conversation, introduction and preparation for a successful application with an experienced consultant
- Transparency and support throughout the application process
- Negotiation with clients for better work/contract conditions
- Follow up and update on market relevant opportunities
For a confidential discussion about quality assurance vacancies, then send your CV to me, Martin Ivanov, Senior Recruitment Consultant for Switzerland.
Keywords: medical devices, medical device, MDD, MDR, regulatory affairs, RA, manager, support, submissions, project management, CFR 820, ISO 13485
Established in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.